510(k) · Cleared
ClearedSynchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · KXT Enzyme Immunoassay, Digoxin
Cleared on Oct 14, 1998 as substantially equivalent to K882233 (Abbott Laboratories, 1988) after a 54-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Oct 14, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- KXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882233 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK882233 TDX (R) Digoxin NXTAbbott Laboratories · 1988
- This deviceK982935 Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug…Beckman Coulter, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK993473 Synchron Systems Drug Calibrator 2Beckman Coulter, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K993473Synchron Systems Drug Calibrator 2Beckman Coulter, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882233 | TDX (R) Digoxin NXT | Abbott Laboratories | 1988 | — |
| 0 (this device) | K982935 | Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator | Beckman Coulter, Inc. | 1998 | — |
| +1 | K993473 | Synchron Systems Drug Calibrator 2 | Beckman Coulter, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXT device
- #1 K193397 ADVIA Centaur® Digoxin assayscore 1.7 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882233 | TDX (R) Digoxin NXTSummary page 1…R §862.3320) Calibrator (21 CFR §862.3200) 4.0 Predicate Device(s): SYNCHRON :System:s - Reagent dicate Manufacturer SYNCHRON® TDx®™* Digoxin Il Abbott* Laboratories, K882233 Systems Digoxin . Inc (DIGN) . *Abbott Laboratories, Abbott Park, IL 60064 **Trademark of Abbott Laboratories 5.0 Description:… | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993473 | Synchron Systems Drug Calibrator 2 | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KXT devicesKXT Enzyme Immunoassay, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXT
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KXT
Too few KXT 510(k)s in any year since 2007 to give a median.
Recalls per year · KXT
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXT
7in 2024
MAUDE reports naming product code KXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 3 | 310 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SYNCHRON® Systems Digoxin (DIGN) Reagent, when used in conjunction with
Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set,
is intended for the quantitative determination of total digoxin in human serum or
plasma on SYNCHRON® Systems.
The SYNCHRON® Systems Drug Calibrator 2, used in conjunction with
SYNCHRON® Digoxin reagent, is intended for use on Beckman's SYNCHRON
Systems for the calibration of Digoxin test systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982935: Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982935
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026